Optical biopsy forceps system and method of diagnosing tissue

ABSTRACT

A biopsy forceps device is provided for obtaining tissue samples at a site within the body, while maintaining access to the site through an access lumen of the biopsy forceps. The device includes an elongate tubular body for introduction into the body and navigation to an area of interest. An inner tubular member having a lumen, or a plurality of lumens, extends through or adjacent the outer tubular member, from the proximal end to the distal end, where cutting jaws are provided. The cutting jaws are rotatably mounted at the distal end of the device and are controlled by movement of the inner tubular member. The inner tubular member is coupled with a handle portion allowing control of the cutting jaws at the proximal end. Access to the lumen of the inner tubular member is gained at the proximal end, where a luer fitting is provided. The lumen of the inner tubular member has a removable optical fiber disposed therethrough and allows for a variety of medical instruments to be inserted so that the instruments can be used coaxially in the same location as where the biopsy sample is taken.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is related to the following co-pending, commonlyassigned U.S. patent applications: application Ser. No. 09/037,722,entitled "OPTICAL BIOPSY SYSTEM AND METHODS FOR TISSUE DIAGNOSIS," filedon even date herewith, and application Ser. No. 08/644,080, entitled"OPTICAL BIOPSY FORCEPS," each of which is assigned to the assignee ofthe present invention, and the entire disclosure of each beingincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical diagnosis andtreatment. More particularly, it pertains to a reusable and disposablebiopsy forceps device having an optical fiber for optical biopsy andhistopathological analysis of tissue.

BACKGROUND OF THE INVENTION

Numerous types of biopsy forceps have been developed for in vivo medicaldiagnosis and treatment of various conditions. Such devices are designedfor sampling tissue within the body, for example in endoscopic,laparoscopic and vascular procedures to retrieve biopsy samples foranalysis and identification of tissue types. These biopsy forcepsdevices generally include small cutting jaws at the distal end, operatedremotely from the proximal end after the distal end of the device hasbeen positioned or navigated to the site of interest.

One difficulty in using prior art biopsy forceps devices is in knowingfor certain the exact positioning of the distal tip, in relation to thesuspected disease area, especially when the area of interest is verysmall. Another difficulty of prior art biopsy forceps in combinationwith other endoscopic accessories is the exact positioning of bothinstruments. Various types of optical catheters or probes have beendeveloped for use in locating or identifying sites within the body. Amethod of diagnosing in vivo using an optical guidewire is disclosed inU.S. Pat. No. 5,439,000, assigned to SpectraScience, Inc. An apparatusand method for identifying and obtaining a biopsy sample is disclosed inpending U.S. application Ser. Nos. 08/643,912 and 08/644,080 licensedand assigned, respectively, to SpectraScience, Inc. The applications areentitled "Optical Biopsy Forceps and Method of Diagnosing Tissue" and"Optical Biopsy Forceps," respectively.

One type of prior art system for internal biopsy uses an opticalcatheter to locate the site, followed by replacement of the opticalcatheter with a biopsy forceps for taking a tissue sample. However, thiscan result in errors and uncertainties in the final placement of thebiopsy jaws with respect to a previously identified small structure ortargeted area since the exact site identified by the optical catheter isnot treated with the biopsy forceps or other instruments to treat thesite.

Other prior art systems have been proposed which use optical viewing orimaging and a cutting device in the same device, to visually locate andthen biopsy a suspected area. However, such devices have been hamperedby their thickness which is needed to accommodate the imaging system andthe cutting actuation system, and which precludes their use in verysmall areas. Another shortcoming of such prior art systems is the offsetor `parallax` between the viewing axis or the imaging system and thecutting position of the biopsy jaws, such that the biopsy sampleactually is taken from a zone slightly displaced from the zone beingviewed by the optics. This can result in a loss of accuracy in the caseof very small structures of interest.

Another difficulty in conventional devices is accessing the area fromwhich the biopsy sample is to be taken. Often the area to be sampledrequires treatment before the sample is taken. An optical catheter isused to locate the biopsy site, followed by replacement of the opticalcatheter with a medical instrument for treating the area. The instrumentis removed, and biopsy forceps is inserted for taking a biopsy sample.However, this can result in errors and uncertainties in the finalplacement of the biopsy jaws with respect to a previously identifiedsmall structure or biopsy area.

Other biopsy devices allow for a biopsy sample to be pierced with aspike before the biopsy sample is taken. However, these devices arelimited to the fixed instrument disposed within the forceps. Ifadditional instruments and treatment is necessary for the biopsy area,the biopsy device must be removed from the body, and a different deviceinserted into the body. Removing the device to insert another posesadditional problems in that the exact biopsy location will not betreated.

Accordingly, a better way to treat biopsy areas is needed. What isfurther needed is a device to accommodate multiple methods of treatmentfor an exact biopsy area. What is also needed is a better way to obtaina biopsy sample.

SUMMARY OF THE INVENTION

To overcome these and other problems, an integrated biopsy forcepsdevice is provided, which is very thin, with an access lumen enablingthe device to be used in very small areas of interest, and which allowsfor accurate alignment with repetitive withdrawal or introductions ofvarious adjunctive medical instruments to treat the biopsy samplingarea. A system is also provided where an integrated biopsy forcepsdevice is coupled with an electro-optical diagnostic apparatus foroptical biopsy to perform histopathological analysis of tissue.

The present invention, in one embodiment, provides a biopsy forcepswhich is adapted for tissue treatment and identification through theaccess lumen and by biopsy sampling. The forceps device includes anelongated catheter body for introduction into the body and navigation toan area of interest. The distal end of the forceps device has a pair ofcutting jaws, and a lumen extends through the forceps device aligningwith the closed cutting position of the cutting jaws. The proximal endhas a handle portion for manipulating the forceps device and actuatingthe jaws.

In accordance with one aspect of the invention, there is provided amethod of treating tissue at a site within a body. The method comprisesintroducing into the body a biopsy forceps which includes a flexiblecatheter body with an access lumen extending therethrough with thedistal end of the lumen aligned with a biopsy sampling area adjacent thedistal tip of the catheter body. Instruments such as an optical fiber,are inserted into the device and through the lumen to treat the samplingarea as appropriate. The biopsy forceps additionally include cuttingjaws mounted at the distal end of the catheter body for selectiveopening and closing in a biopsy cutting movement in the biopsy samplingarea, and an actuator mechanism operatively connected to the jaws forselectively controlling the opening and closing of the cutting jaws.Then, tissue in the biopsy sampling area adjacent the distal end of theforceps is treated with the instruments inserted through the forceps oridentified by the optical fiber coupled with the electro-opticaldiagnostic apparatus. Alternatively, the area is flushed with medicineor saline with or without the optical fiber inserted in the lumen. Then,a biopsy sample is cut from the location of the optical tissue analysiszone by actuating the actuator mechanism, and the biopsy sample iswithdrawn from the body.

In one embodiment, the cutting jaws are mounted for pivoting aboutstationary pivot pins for cutting tissue placed there between, andcoupled to and controlled by an inner tubular member forming the lumenthat extends through the catheter body to the handle portion at theproximal end of the device. The inner tubular member extends through thehandle and couples with an access portion on the handle portion.Instruments, medicine, or fluids are inserted into the access portionand through the lumen to treat, flush, or clean the biopsy samplingarea. The inner tubular member is positioned coaxially with the jaws, sothat the biopsy sample is taken exactly at the spot where treatment withinstruments or fluids took place. In an alternative configuration, asecond lumen is provided adjacent the lumen within the inner tubularmember to provide additional access proximate the biopsy sampling area.

In another embodiment, the cutting jaws are mounted for pivoting aboutstationary pivot pins for cutting tissue placed therebetween, andcontrolled by control wires extending through the catheter body to thecontrol handle and/or an inner member. Alternatively, the cutting jawsare rotatably coupled with a distal housing and are controlled by links.The links, in another embodiment, are operatively coupled with theactuator housing and the cutting jaws. The inner member has a lumentherein and extends through the device, from its proximal end forcoupling with an access port. An optical fiber is disposed within thelumen of the inner member. The control wires are disposed in groovesformed in the inner member and the wires and the inner member arecoupled with a handle for actuating the cutting jaws.

In yet another embodiment, the cutting jaws are mounted for pivotingabout stationary pivot pins and are for cutting tissue placed betweenthe cutting jaws, and coupled to and controlled by an inner tubularmember that extends through the catheter body to the handle portion atthe proximal end of the device. The inner tubular member has a pluralityof lumens therein with an optical fiber disposed in at least one of thelumens, and extends through the handle and couples with an accessportion on the handle portion. Instruments, medicine, or fluids areinserted into the access portion and through the lumen to treat thebiopsy sampling area. The inner tubular member is positioned coaxiallywith the jaws, so that the biopsy sample is taken exactly at the spotwhere treatment with instruments or fluids took place.

According to one aspect of the invention, the biopsy forceps isreusable. When the optical fiber needs to be replaced, the entire biopsyforceps does not need to be discarded. Instead, a new optical fiber isinserted through the central access lumen when the use of the previousoptical fiber is exhausted. Removing the optical fiber from the biopsyforceps also allows for the forceps to be cleaned and sterilized moreextensively using more thorough and strenuous processes.

According to another aspect of the invention, the biopsy forceps isdisposable. Using disposable biopsy forceps helps to reduce the chanceof contamination between patients where a biopsy forceps is disposedafter use on one patient, which is ideal for patients with highlycontagious and dangerous diseases or patients highly susceptible toinfection.

One important use of the invention is in connection with endoscopictreatment and diagnosis procedures, for example in gastrointestinalendoscopy or bronchoscopy. The present invention is also useful in manyother endoscopic fields including, but not limited to: urology,cardiovascular, neurology, orthopedics, general surgery, laparoscopy,obstetrics/gynecology, etc. It can also be used in minimally invasivelaparoscopic procedures for additional diagnostic information, and/orguidance of a therapeutic modality (e.g., laser or cutting/coagulationdevices, such as a bipolar or monopolar electrocautery RF device).

These and other features and advantages of the invention will becomeapparent from the following description of the preferred embodiments ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a first side elevational view of a biopsy forceps connected toa diagnostic apparatus shown in schematic diagram constructed inaccordance with one embodiment of the present invention.

FIG. 2 is a first side elevational view illustrating biopsy forcepsconstructed in accordance with one embodiment of the present invention.

FIG. 3 is a first side elevational view illustrating biopsy forcepsconstructed in accordance with one embodiment of the present invention.

FIG. 4a is a first side elevational view illustrating an actuatorhousing for use with biopsy forceps constructed in accordance with oneembodiment of the present invention.

FIG. 4b is a second side elevational view illustrating the actuatorhousing for use with biopsy forceps constructed in accordance with oneembodiment of the present invention.

FIG. 5a is a perspective view illustrating a cutting jaw for use withbiopsy forceps constructed in accordance with one embodiment of thepresent invention.

FIG. 5b is a first side elevational view illustrating a cutting jaw foruse with biopsy forceps constructed in accordance with one embodiment ofthe present invention.

FIG. 6 is a perspective view illustrating a distal housing for use withbiopsy forceps constructed in accordance with one embodiment of thepresent invention.

FIG. 7 is a first side elevational view illustrating biopsy forcepsconstructed in accordance with another embodiment of the presentinvention.

FIG. 8 is a cross-sectional view taken along 8--8 of FIG. 7 illustratingbiopsy forceps constructed in accordance with one embodiment of thepresent invention.

FIG. 9 is a first side elevational view illustrating a translatingmember assembly for use with biopsy forceps constructed in accordancewith one embodiment of the present invention.

FIG. 10 is a first side elevational view illustrating an actuatorhousing for use with biopsy forceps constructed in accordance with oneembodiment of the present invention.

FIG. 11 is a first side elevational view illustrating biopsy forcepsconstructed in accordance with one embodiment of the present invention.

FIG. 12a is a first side elevational view illustrating biopsy forcepsconstructed in accordance with one embodiment of the present invention.

FIG. 12b is a cross-sectional view taken along 12b--12b of FIG. 12aillustrating biopsy forceps constructed in accordance with oneembodiment of the present invention.

FIG. 13 is a first side elevational view illustrating biopsy forcepsconstructed in accordance with one embodiment of the present invention.

FIG. 14 is a cross-sectional view taken along 14--14 of FIG. 13illustrating biopsy forceps constructed in accordance with oneembodiment of the present invention.

FIG. 15a is a first side elevational view illustrating biopsy forcepsconstructed in accordance with one embodiment of the present invention.

FIG. 15b is a cross-sectional view taken along 15b--15b of FIG. 15aillustrating biopsy forceps constructed in accordance with oneembodiment of the present invention.

FIG. 16a is a first side elevational view illustrating a biopsy forcepshaving an ultrasonic probe disposed therethrough in accordance with oneembodiment of the present invention.

FIG. 16b is a first side elevational view illustrating a biopsy forcepshaving a guidewire disposed therethrough in accordance with oneembodiment of the present invention.

FIG. 16c is a first side elevational view illustrating a biopsy forcepshaving a snare disposed therethrough in accordance with one embodimentof the present invention.

FIG. 16d is a first side elevational view illustrating a biopsy forcepshaving a cytology brush disposed therethrough in accordance with oneembodiment of the present invention.

FIG. 16e is a first side elevational view illustrating a biopsy forcepshaving a needle disposed therethrough in accordance with one embodimentof the present invention.

FIG. 16f is a first side elevational view illustrating a biopsy forcepshaving saline flushed therethrough in accordance with one embodiment ofthe present invention.

FIG. 16g is a first side elevational view illustrating a biopsy forcepshaving an instrument inserted therethrough in accordance with oneembodiment of the present invention.

DESCRIPTION OF THE EMBODIMENTS

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that other embodiments may be utilized and that structuralchanges may be made without departing from the spirit and scope of thepresent invention. Therefore, the following detailed description is notto be taken in a limiting sense, and the scope of the present inventionis defined by the appended claims.

FIG. 1 illustrates a system including a biopsy forceps 10 and adiagnostic apparatus 1000, such as a spectrophotometer. In oneembodiment, the electro-optical diagnostic apparatus 1000 comprises alight source 1030, a spectral analyzer 1040, and a computer 1050.Forceps 10 includes an optical fiber 900 disposed therethrough, as isexplained in greater detail below. The optical fiber 900 is coupled withthe fiber coupler 1020 and the light source 1030 of the diagnosticapparatus 1000.

During use, the light source 1030 provides a source of opticalradiation, where operation of the light source 1030 is, in oneembodiment, controlled by the computer 1050. Operation of the lightsource 1030 transmits radiation into the fiber coupler 1020. Theradiation emanates from the optical fiber 900 upon a tissue location(not shown). The radiation returning from the tissue by reflection orfluorescence is received by the optical fiber 900 and the fiber coupler1020 which then transmits the returning radiation to the spectralanalyzer 1040. In another embodiment, the computer 1050 further analyzesthe information from the spectral analyzer 1040 and outputs theinformation to a display (not shown). The system is not limited to thediagnostic technique described above. Rather, the system according tothe present invention is designed for use in methods utilizing anyoptically based diagnostic techniques, including laser inducedfluorescence, time-resolved fluorescence, Raman spectroscopy, opticalcoherence tomography, etc. Alternative techniques of diagnosing tissuefrom the data received from the optical fiber will be known to thoseskilled in the art and will not be described further herein.

The biopsy forceps 10 is shown in greater detail in FIG. 2. The biopsyforceps 10 is adapted for use internally of the body, for example inconnection with endoscopic, laparoscopic or vascular procedures. Forceps10 includes a control handle portion 12 at a proximal end 15, a middleportion 14 which extends over the main length of the device, and adistal end 16 which includes opposed forceps cutting jaws 120, as isexplained in greater detail below.

The main body or length of the forceps 10 consists of coaxial inner andouter tubular members 20, 22, as shown in more detail in FIG. 3. Theouter tubular member 22 is small enough such that it can be insertedwithin a working channel of an endoscope. In one embodiment, the innertubular member 20 is a stainless steel tube, and the outer tubularmember 22 or catheter body is a coil. In another embodiment, the innertubular member 20 comprises a coiled stainless steel tube. For eitherthe inner tubular member 20 or the outer tubular member 22 having thecoiled stainless steel configuration, the coil is a finely wound spiralcoil of stainless steel as is generally known and used in catheters andguidewires. Alternatively, the outer tubular member 22 or the innertubular member 20 could be made using a plastic tube, or a plastic/metalcomposite structure, in place of the coil.

The inner tubular member 20 is positioned within the outer tubularmember 22 and these components are dimensioned with respect to eachother so that inner tubular member 20 moves freely within the outertubular member 22 to actuate the jaws, as is explained in more detailbelow. The inner tubular member 20 has a central access lumen 28extending through the inner tubular member 20 from the proximal end 15to the distal end 16. The access lumen 28 is sized to receive theoptical fiber 900 therethrough. The optical fiber 900, in oneembodiment, is removably disposed within the access lumen 28. The accesslumen 28 is sized larger than the optical fiber 900, in one embodiment,such that a fluid (e.g. saline) can be flushed through the forceps 10 toclean the lumen 28, the area of interest or to clean the distal portionof the optical fiber 900. In another embodiment, a variety of medicalinstruments can be inserted through the lumen 28 when the optical fiber900 is removed, as shown in FIGS. 16a-16g, and as will be discussedfurther below. The inner tubular member 20 is coupled with an actuatorhousing 60.

The actuator housing 60, shown in more detail in FIGS. 4a and 4b is, inone embodiment, fabricated from stainless steel material. Alternatively,the actuator housing 60 can be formed from other substantially rigidmaterials. The actuator housing 60 extends from a first end 62 to asecond end 64, and generally comprises an elongate cylinder. Inaddition, the actuator housing 60 has flats 66 formed proximate thefirst end 62. Disposed on the flats 66 are cam pins 68 having agenerally circular cross-section, as shown. In one embodiment, the campins 68 are integral with the flats 66 of the actuator housing 60. Toform the cam pins 68 integrally with the flats 66, the actuator housing60 can be machined or molded from a single piece of material.Alternatively, the cam pins 68 can be integrally formed with the flats66 by attaching the projections to the flats 66 using, for example,adhesive or welding processes. The cam pins 68 are for coupling with thejaws, as will be further explained below.

The actuator housing 60 has a bore 70 extending from the first end 62 tothe second end 64, where the bore has a first portion 72 and a secondportion 74. The first and second portions 72, 74 form a shoulder 76 inbetween. The first portion 72 has a smaller diameter than the innertubular member 20, yet large enough to allow the optical fiber 900 topass through the first portion 72. In one embodiment, the first portion72 is large enough to allow other medical devices to pass through, suchas the devices shown in FIGS. 16a-16g. The inner tubular member 20 isinserted within the second portion 74 of the actuator housing 60 until,in one embodiment, inner tubular member 20 contacts the shoulder 76 ofthe actuator housing 60. In another configuration, the inner tubularmember 20 can be placed proximate to shoulder 76. The access lumen 28 ofthe inner tubular member 20 is substantially aligned with the bore 70 ofthe actuator housing 60, thereby facilitating insertion of the opticalfiber 900 or the medical devices through the access lumen 28 and throughthe bore 70. The inner tubular member 20 is coupled with the actuatorhousing 60, where in one embodiment, the inner tubular member 20 issecured to the actuator housing 60 with a weld 78. Alternatively, theinner tubular member 20 can be joined with the actuator housing 60 bysolder, brazing, or adhesive techniques as is known by those skilled inthe art.

FIGS. 3, 5a and 5b show the cutting jaws 120 in more detail. The cuttingjaws 120 are comprised of a first jaw 122 and a second jaw 124 which, inone embodiment, are mirror images of each other. Since the first jaw 122and the second jaw 124 are similar, only the first jaw 122 will bediscussed. The jaw 122 has an actuation portion 132 and a cuttingportion 136. Within the cutting portion 136, the jaw 122 has ahemispherical cup 126 with sharpened edges 130 for taking biopsysamples. The cup 126 of jaw 122 has, in one embodiment, a hole 128disposed therein. The hole 128 advantageously facilitates cutting thebiopsy sample at the site within the body, and also facilitates theremoval of the biopsy specimens captured by each cup 126.

Referring to the actuation portion 132, the jaw 122 has a cut out 138for forming a pivot point for the jaw 122. The cut out 138 is generallycircular in shape and sized to receive a projection of a distal housing,as will be further discussed below. The actuation portion 132 alsoincludes a cam slot 140, which in one embodiment is arcuately shaped.The cam slot 140 couples with the cam pin 68 of the actuator housing 60.The cam slot 140 is sized to receive the cam pin 68 therein, and allowsfor radial movement of the jaw 122 about the pivot point as the cam pin68 of the actuator housing 60 is moved along the axis of the biopsyforceps 10. The movement of the jaw 122 about the pivot point allows forradial movement of the cutting jaws 120, without axial movement of thecutting jaws 120. This provides a further benefit since the jaws moreaccurately cut the biopsy sample at the exact position identified usingthe optical fiber 900.

Biopsy forceps 10 also includes a distal housing 90, as shown in moredetail in FIG. 6. The distal housing 90 is a generally elongate cylinderhaving a radial axis 106 and extending from a first end 92 to a secondend 94. The housing 90 is fabricated from, in one embodiment, stainlesssteel material. Disposed proximate the first end 92 are flats 96. In oneembodiment, the flats 96 each form a surface which is parallel to eachother. The flats 96 each have a pivot pin 100 disposed thereon. Thepivot pin 100 couples with the cut out 138 in each of the cutting jaws120, and allows the cutting jaws 120 to rotate about the pivot pin 100.The flats 96 have a cut out 98 extending through the housing 90. In oneembodiment, the cut out 98 is generally square shaped and is disposedperpendicular to the radial axis 106 of the housing 90, as shown in FIG.6. The cut out 98 is sized to allow the actuator housing 60 to travelalong the radial axis 106 of the housing 90 sufficient to actuate thecutting jaws 120 without interference from the distal housing 90.

Extending through the housing 90 is a bore 102. The bore 102 is alignedwith the radial axis 106 of the housing 90 and extends from the firstend 92 to the second end 94. The bore 102 has its largest diameterproximate the second end 94, and tapers to a second bore portion 108.The housing 90 has a third bore portion 110 proximate the first end 92of the housing 90. The bore 102 is sized to receive the outer tubularmember 22 therein. The outer tubular member 22 is secured to the housing90 by welding, brazing, soldering, adhesives, or other equivalents knownto those skilled in the art. The second bore portion 108 is sized toreceive the actuator housing 60 therethrough, and to allow the actuatorhousing 60 to travel axially to actuate the jaws 120. The third boreportion 110 is sized to freely receive the optical fiber 900 or medicaldevices such as those shown in FIGS. 16a-16g, such that the fiber 900 orthe devices can be used through the cutting jaws 120.

Referring again to FIG. 1, the biopsy forceps 10 includes the handleportion 12 for facilitating actuation of the inner tubular member 20.The handle portion 12 includes a handle 42 and a translation member 46,and loops 24, 25, 26. Loops 24, 25, 26 are provided in the handleportion 12 to form finger holes useful in grasping and manipulating theforceps 10. The handle 42 is fastened to the translation member with afastener 44. The inner tubular member 20 is fastened to the translationmember by welding, brazing, soldering, adhesives, or other mechanicalfasteners such that movement of the handle 42 results in movement of theinner tubular member 20. In addition, a luer fitting 48 is threaded intothe translation member 46. The translation member 46 has a bore (notshown) therethrough, which provides a conduit between the luer fitting48 and the inner tubular member 20. The luer fitting 48 in combinationwith the bore of the translation member 46 provide access to the lumen28 and allows for ease of cleaning and reusability of the biopsy forceps10. The handle portion 12 can include any type of actuating mechanismcapable of imparting bidirectional axial movement to the inner tubularmember 20 of biopsy forceps 10.

Referring to FIGS. 1 and 2, in operation, the handle 42 is retractedtoward the back of handle portion 12 to close the jaws. Retraction ofthe handle 42 causes movement of the inner tubular member 20 and theactuator housing 60 toward the handle portion 12, and closes the cuttingjaws 120. In this configuration, the distal end 16 of the forceps 10 isof the same narrow diameter as the main body of a forceps catheter, andthe closed jaws have a smooth, rounded shape to facilitate introductionand navigation in the vascular, endoscopic or laparoscopic systems. Inaddition, the cutting jaws are coaxially positioned with respect to thedistal end of the inner tubular member 20.

The endoscopist advances the biopsy forceps 10 through a working channelof the endoscope to the general area of interest, i.e., such as a tissuesite. Once in place in the general area of interest, the forceps jawscan be opened by advancing the handle 42 toward the distal end 16 of theforceps 10, thereby advancing the translating member 46 away from thehandle 42. This causes the inner tubular member 20 to move away from thehandle 42, which in turn causes the actuator housing 60 to be axiallymoved towards the distal end 16 of the forceps. As the actuator housing60 moves, the cam pins 68 on the actuator housing 60 move within the camslots 140 of the cutting jaws 120, causing the cutting jaws 120 to open.

When a biopsy area is identified by the optical fiber 900 usingspectrophotometric analysis and/or selected by other methods, the areacan now be treated through the lumen using various medical instruments,flushed with saline, or treated with medicine. If other medicalinstruments are necessary, the optical fiber 900 is removed from thelumen 28, and a new instrument is inserted therein. If a biopsy of thearea is necessary, the handle 42 is retracted toward the proximal end 15of the forceps 10, retracting the inner tubular member 20, and causingthe cutting jaws 120 to close and cut a biopsy sample at the exact placethat had been treated and/or identified. To take the tissue sample, theendoscopist holding the instrument by the handle portion 12, gentlypulls back on the handle 42, retracting the inner tubular member 20, andclosing the cutting jaws 120 on the biopsy sample. When the jaws 120 areclosed, the endoscopist pulls the entire assembly away from the tissuesurface and out of the body. To retrieve the specimen sample from thecutting jaws 120, an instrument is inserted into the hole 128 in thehemispherical cup 126 of one of the cutting jaws 120 or the cutting jaws120 can be flushed with saline to remove the sample.

Referring to FIG. 7, another embodiment of a biopsy forceps of thepresent invention is generally indicated by reference number 200. Thebiopsy forceps 200 is generally similar to the biopsy forceps 10 shownin FIG. 1, and accordingly, corresponding elements have been given thesame reference number. The biopsy forceps is adapted for use internallyof the body, for example in connection with endoscopic, laparoscopic orvascular procedures. The forceps 200 includes a handle portion 12 at theproximal end 15, a middle portion 14 which extends over the main lengthof the device, and a distal end 16. The distal end 16 includes forcepscutting jaws 120.

The forceps 200 has a coaxial inner member 220 and an outer tubularmember 222, as shown in FIG. 8. The outer tubular member 222 and theinner member 220 each extend generally from the proximal end 15 to thedistal end 16 of the forceps 200. The outer tubular member 222, in oneembodiment, comprises a finely wound spiral coil of stainless steel asis generally known and used in catheters and guidewires. Alternatively,the outer tubular member 222 could be made using a plastic tube, or aplastic/metal composite structure, in place of the stainless steelspiral coil. The outer tubular member 222 has a lumen therethrough whichis sized to received the inner member 220 therein.

In one embodiment, the inner member 220 comprises a polymer tube whichis extruded with a lumen 230 therein. Alternatively, the inner member220 comprises a plastic tube or a combination of metal and plastic. Thelumen 230 is sized to receive an optical fiber 250 therein. Secured toat least a portion of the optical fiber 250, the inner member 220 formsa cladding for the optical fiber 250. In addition, grooves 232, 234 areformed in the perimeter of the inner member 220. The grooves 232, 234form a cavity within the inner member 220 and can also take the form ofan indentation or a lumen. In another embodiment, the grooves 232, 234are disposed on opposite sides of the lumen 230. Positioned within thegrooves 232, 234 of the inner member 220 are a pair of control wires240, 241, which in one embodiment comprise stainless steel cables. Thesecomponents, together with outer tubular member 222 and inner member 220extend over the main length of the device, from the distal end 16 to thehandle portion 12 (FIG. 7).

The handle portion 12 includes a translating member 244, which in oneembodiment, comprises an aluminum block. The handle 242 is fastened tothe translation member 244 with fastener 44. Both the inner member 220and the control wires 240, 241 are secured to the translating member244, shown in more detail in FIG. 9. The translating member 46 has aprojection 246 for securing the inner member 220 with the handle 242.The projection 246, comprising a generally elongate cylinder, has ridges248, 249 disposed around the perimeter of the projection 246. The ridges248, 249 of the projection 246 engage the lumen 230 of the inner member220 and prevent the inner member 220 from disengaging from the handle242. The control wires 240, 241 are secured to the translating member244 by either welding, soldering, brazing, adhesives, a mechanicalfastener, or other alternatives as known by those skilled in the art.

The inner member 220 and the control wires 240, 241 are secured totranslating member 244 which together, in one embodiment, form anactuator mechanism for the forceps 200. Movement of translating member244 causes axial movement of the inner member 220 and the control wires240, 241 relative to outer tubular member 222, which is used to actuatethe cutting jaws 120. Loops 226, 227, and 228 are provided in handleportion 12 to form finger holes useful in grasping and manipulating theforceps 200 (FIG. 7).

The inner member 220 extends from the handle portion 12 to the distalend 16. Coupled to the inner member 220 and the control wires 240, 241at the distal end 16 is an actuator housing 260. The actuator housing260, shown in more detail in FIG. 10 is, in one embodiment, fabricatedfrom stainless steel material, and generally comprises an elongatecylinder. The actuator housing 260 extends from a first end 262 to asecond end 264, and has flats 266 formed proximate the first end 262.Disposed on the flats 266 are cam pins 268 having a generally circularcross-section, as shown. In one embodiment, the cam pins 268 areintegral with the flats 266 of the actuator housing 260. To form the campins 268 integrally with the flats 266, the actuator housing 260 can bemachined or molded from a single piece of material. Alternatively, thecam pins 268 can be integrally formed with the flats 266 by attachingthe cam pins 268 to the flats 266 using, for example, adhesive orwelding processes. The cam pins 268 are for coupling with the jaws 120,as will be further explained below.

The actuator housing 260 has a bore 270 which extends through theactuator housing 260 from the first end 262 to the second end 264 and issized to receive the optical fiber 250 therethrough. The bore 270 of theactuator housing 260 aligns with the lumen 230 of the inner member 220so that access to the distal end 16 is not prevented. The bore 270allows for the optical fiber 250 to be inserted through the innertubular member 220 and through the actuator housing 260 to the cuttingjaws 120.

The actuator housing 260 has attachment features so that the innermember 220 can be coupled with the actuator housing 260. In oneembodiment, the actuator housing 260 has ridges 272 disposed about theperimeter of the actuator housing 260, proximate to the second end 264.The ridges 272 engage the surface of the lumen 230 to retain the innermember 220 on the actuator housing 260. Alternatively, the actuatorhousing 260 can be coupled with the inner member 220 in other manners,for example, adhesives. The control wires 240, 241 are also secured tothe actuator housing 260. In one embodiment, the control wires 240, 241are secured to the actuator housing at reference number 255 by eitherwelding, soldering, brazing, adhesives, or a mechanical fastener. Duringuse, both the actuator housing 260 and the control wires 240, 241provide the axial force to the actuation portion 132 of the cutting jaws120.

The biopsy forceps 200 has a distal housing having the same structure asdiscussed above, and as shown in FIG. 6. The outer tubular member 222 ofthe biopsy forceps 200 is secured to the housing, as in the previousembodiment, and therefore will not be further discussed. The biopsyforceps 200 also includes cutting jaws 120.

The cutting jaws 120 are also the same as in the previous embodiment,and one of the cutting jaws 120 is as shown in FIGS. 5a and 5b.Referring to the actuation portion 132, the jaw 122 has a cut out 138and a cam slot 140. The cut out 138 forms a stationary pivot point forthe jaw 122, and receives the pivot pins 100 of the housing 90 therein.The cam slot 140 couples with the cam pins 268 of the actuator housing260, and allows for radial movement of the jaw 122 about the pivot pointas the cam pins 268 of the actuator housing 260 are moved along the axisof the biopsy forceps 200. A further benefit is obtained since thecutting jaws 120 do not move axially during the cutting process.Instead, the cutting jaws 120 rotate about the stationary pivot point.This allows for more precise cutting of the biopsy site identified bythe optical fiber.

During operation, referring to FIG. 7, the handle 242 is retractedtoward the back of handle portion 12 to close the jaws. This causesmovement of the inner member 20, the control wires 240, 241, and theactuator housing 260 toward the handle portion 12, and closes thecutting jaws 120. In this configuration, the distal end 16 of theforceps 10 is of the same narrow diameter as the main body of a forcepscatheter, and the closed jaws have a smooth, rounded shape to facilitateintroduction and navigation in the vascular, endoscopic or laparoscopicsystems. In addition, the cutting jaws are coaxially positioned withrespect to the distal end of the inner tubular member.

Once in place in the general area of interest, the cutting jaws 120 canbe opened by pushing handle 42 of the control handle forward, away fromthe handle portion 12. This causes movement of the translation member244, the inner member 220, the control wires 240, 241, and the actuatorhousing 260 away from the handle portion 12. The control wires 240, 241and the inner member 220 push against the actuator housing 260. As theactuator housing 260 moves away from the handle portion 12, the cam pins268 on the actuator housing 260 move within the cam slots 140 of thecutting jaws 120, and cause the jaws 120 to open. The distal end 16 ofthe forceps 10 is positioned at the area of contact. The optical fiber250, when connected to the electro-optic diagnostic apparatus, can thenbe used for optical biopsy to perform histopathological analysis of thetissue site. When an area of disease is identified and a biopsy of thearea is needed, the handle 242 is pulled toward the proximal end 15 ofthe forceps 10, causing the jaws 120 to close and cut a biopsy sample.The biopsy sample is cut from the exact tissue site identified as thebiopsy site without requiring moving or repositioning of the catheterbody. The forceps may then be withdrawn from the patient to recover thesample for analysis. The analysis of the withdrawn sample can beconducted using known laboratory techniques to confirm theidentification of the tissue sample.

FIG. 11 illustrates another embodiment of an optical biopsy forceps 280.The optical biopsy forceps 280 includes cutting jaws 304, a coaxialinner member 276 and an outer tubular member 278 which each extendproximate the distal end of the forceps 280. In one embodiment, theinner member 276 is extruded with a lumen 282 therein. Alternatively,the inner member 276 comprises a plastic tube or a combination of metaland plastic. The lumen 282 is sized to receive an optical fiber 900therein.

The inner tubular member 276 is positioned within the outer tubularmember 278 and these components are dimensioned with respect to eachother so that inner tubular member 276 moves freely within the outertubular member 278 to actuate the jaws 304. The optical fiber 900, inone embodiment, is removably disposed within the lumen 282. The innertubular member 276 is coupled with an actuator housing 290 such thatmovement of the inner tubular member 276 causes movement of the actuatorhousing 290.

The actuator housing 290 is, in one embodiment, fabricated fromstainless steel material. Alternatively, the actuator housing 290 can beformed from other substantially rigid materials. The actuator housing290 includes at least one pin 292. The pins 292 are adapted to couplewith a link coupling 297 of a first and second link 296, 298.

The actuator housing 290 has a bore 294 therethrough, which allowspassage of the optical fiber 900 therethrough. The bore 294 of theactuator housing 290 is aligned with the lumen 282 of the inner tubularmember 276, thereby facilitating insertion of the optical fiber 900, orother medical device through the access lumen 282 and through the bore294. The inner tubular member 276 is coupled with the actuator housing290, where in one embodiment, the inner tubular member 276 is secured tothe actuator housing 290 with a weld. Alternatively, the inner tubularmember 276 can be joined with the actuator housing 290 by solder,brazing, or adhesive techniques.

The cutting jaws 304 are comprised of a first jaw 306 and a second jaw308. The cutting jaws 304 each have a cut out 310 for forming a pivotpoint for each jaw 304. The cut out 310 is generally circular in shapeand sized to receive a projection of a distal housing 284, as will befurther discussed below. The cutting jaws 304 each have a coupling 312for attaching the jaws 304 with a link coupling 297 the first and secondlinks 296, 298. In one embodiment, the coupling 312 comprises a lug 314disposed on the jaws 304, which couples with the link coupling 297 ofthe first and second links 296, 298.

The forceps 280 also includes a distal housing 284. The distal housing284 includes at least one pivot pin 286 disposed thereon. Each pivot pin286 is adapted to couple with the cut out 310 in each of the cuttingjaws 304, and allows the cutting jaws 304 to rotate about the pivot pin286. The distal housing 284 has a lumen 288 therein which allows passageof the optical fiber 900 therethrough.

In an alternative embodiment, control wires (See FIGS. 7-9) could becoupled with the first and second links 296, 298. For thisconfiguration, the control wires would apply an axial force to the firstand second links 296, 298, and would be used to rotate the cutting jaws304 about the pivot pins 286. In addition, the inner tubular member 276would be directly coupled with the distal housing 284.

During operation, the handle 42 (FIGS. 1 and 2) is retracted to closethe jaws 304. Retraction of the handle 42 causes axial movement of theinner tubular member 276 and the actuator housing 290 toward the handle42, and closes the cutting jaws 304. After the endoscopist advances thebiopsy forceps 280 through a working channel of the endoscope to thegeneral area of interest, the jaws 304 can be opened by advancing thehandle 42 toward the distal end of the forceps 280. Advancing the handle42 causes the inner tubular member 276 to move away from the handle 42,which in turn causes the actuator housing 290 to be axially movedtowards the distal end of the forceps. As the actuator housing 290moves, the first and second links 296, 298 push upon the jaws 304causing the first and second links 296, 298 to rotate around thecouplings on both the actuator housing 290 and the jaws 304. As thelinks rotate, the cutting jaws 304 rotate about the pivot pins 286 onthe distal housing 284 and move to an open position.

The above described embodiment provides many advantages overconventional forceps. For instance, the inner member 220 and the controlwires 240, 241 (FIG. 7) both actuate the radial movement of the cuttingjaws 120. The combination of devices allows the operator to apply moreaxial force to the inner member 220 and the control wires 240, 241thereby resulting in additional torque to the cutting jaws 120. Theadditional torque provides better cutting actuation, particularly inbiopsy sites with tissue that is difficult to cut with the relativelysmall cutting jaws 120. Another advantage of this embodiment is that thebiopsy forceps is disposable, although the biopsy forceps can bereusable. Forming the inner member 220 from the polymer material helpsto provide an inexpensive forceps 10 for disposal after use. Inaddition, using disposable biopsy forceps eliminates the chance ofcontamination between patients where a biopsy forceps is disposed afteruse on one patient, which is ideal for patients with highly contagiousand dangerous diseases or patients highly susceptible to infection.

FIGS. 12a and 12b illustrate yet another embodiment of the presentinvention. A biopsy forceps 300 is provided having multiple accesslumens. The general configuration of the biopsy forceps 300 is the sameas the first discussed embodiment where an inner tubular member 320 isslidably received by an outer tubular member 340. The inner tubularmember 320 actuates the cutting jaws 120, as discussed above. In oneembodiment, the inner tubular member 320 has a plurality of lumensdisposed therein. In at least one of the lumens, an optical fiber isdisposed therethrough. The plurality of lumens allow for othercomponents or materials (such as fluids) to be inserted through theinner tubular member simultaneously with the optical fiber.Alternatively, in another embodiment, a gap 316 between the innersurface of the outer tubular member and the outer surface of the innertubular member 320 provides a secondary lumen 318. The secondary lumen318 allows for fluids such as saline or medicine to be administered tothe biopsy area. During use, the fluids travel through the secondarylumen 318 and are expelled through openings between the distal housing90 and the cutting jaws 120 (FIG. 3) to treat the biopsy area. Access tothe primary lumen is at a primary port 334. To access the secondarylumen 318 or the multiple lumens described above, a secondary port 332is provided proximate the handle portion 12. The secondary port, in oneembodiment, comprises a luer fitting as known by those skilled in theart.

FIGS. 13 and 14 illustrate another embodiment of the present invention.In this configuration, a biopsy forceps 400 are provided with cuttingjaws 480, a handle portion 412, and a main body 414 in between. The mainbody 414 has an inner tubular member 420, which actuates the cuttingjaws 480 and is disposed within an outer tubular member 422, asdiscussed above. Disposed within the inner tubular member 420 is anoptical fiber 450. A third tubular member 424 is coupled with the mainbody 420. In one embodiment, the third tubular member 424 is secured tothe outer surface of the outer tubular member 422 as shown in FIG. 14 bywelding, brazing, soldering, or adhesive. In another embodiment, apolymer heat-shrink jacket 426 is placed over the outer tubular member422 and the third tubular member 424 to thereby couple the third tubularmember 424 with the outer tubular member 422. The outer jacket coatingprovides the forceps 400 with a smooth surface for ease of use withinthe patient.

In another embodiment of the invention, the above biopsy forceps 500 areprovided with electro-cauterizing capability. In this configurationshown in FIGS. 15a and 15b, using the biopsy forceps 500 as describedabove, a connector pin 510 is provided on the handle portion 12. Theconnector pin 510 forms an electrical connection which is compatiblewith standard electro/surgical equipment. In one embodiment, aprotective collar 522 surrounds the connector pin 510, preventinginadvertent contact with the connector pin 510. The collar 522 protectsthe connector pin 510 from being damaged. The inner tubular member 520comprises a stainless steel tube, which is coupled with the connectorpin 510. Alternatively, the inner tubular member 520 comprises a polymertube with steel control wires, as described above. During use, a radiofrequency current is coupled with the connector pin 510. The connectorpin 510 allows a current path to the stainless steel tube, or thestainless steel pull wire, depending on the embodiment. The current pathwould follow the stainless steel tube or wires to the cutting jawsdisposed at the distal end of the biopsy forceps. The jacket 426 acts asan insulator over the length of the forceps 500, with the metallic jawsacting as the cauterizing device. The connector pin 510, as known bythose skilled in the art, is coupled with equipment having theelectro-surgical standard for radio frequency current. The radiofrequency current allows for cauterizing capability of the biopsyforceps 500 in the biopsy site using either mono or bipolar modes.

The lumen of the above biopsy forceps allows for a number of medicalinstruments to be inserted through the biopsy forceps once the opticalfiber is removed, and the instruments are also axially aligned with thecutting jaws. Another embodiment of the present invention includesmedical devices slidably engaged within the access lumen 630 of biopsyforceps 600. As shown in FIGS. 16a-16e, many instruments can be insertedinto the lumen 630 of the inner tubular member 620, including, but notlimited to: ultra sonic probe 710, guidewires 712, a snare 714, acytology brush 716, and a needle 718. In addition, the area to besampled by the biopsy forceps 600 can be flushed with saline 720,medicine, or other fluids as shown in FIG. 16f. Alternatively, suctioncan be applied to the lumen 630 for removing excess loose material orfluid from the biopsy site. As shown in FIG. 16g, each instrument isinserted into an access port 650 and extends through a translatingmember 646, through a middle portion 675, and through cutting jaws 680of the forceps 600. The instruments are used for treating the tissue inthe area adjacent the distal end of the forceps 600, which is alignedwith the axis of the lumen 630.

The present invention has provided a biopsy forceps having an accesslumen and an optical fiber. An important feature of the invention isthat the lumen of the inner tubular member is coaxial with the zonewhere the two jaws intersect and the sample is taken. Thus, there is nooffset error between the spot where the various medical instruments ortreatments are used and the spot from which the biopsy sample will betaken. In addition, the physician has more options in treating the areawhere the biopsy sample is taken. For instance, the area can first beflushed with saline, or treated with medicine. The biopsy forcepsprovides a further advantage in that an area can be treated with salineand/or with medicine without having to remove the biopsy forceps fromthe body. Alternatively, one of many instruments can be used to treatthe biopsy area prior to the biopsy. These features, together with theslim and compact profile of the device when the jaws are retracted, area great improvement over prior art devices. One of the advantages offorceps 10 as compared to forceps 200 is, because the control wires 240,241 are not required, a larger diameter lumen can be used to accommodatelarger sized instruments.

A further advantage of the present invention is that since the opticalfiber 900 is removable from the biopsy forceps 10, the biopsy forceps 10is reusable. When the optical fiber 900 needs to be replaced, the entirebiopsy forceps 10 does not need to be discarded. Instead, a new opticalfiber 900 is inserted through the central access lumen 28 when the useof the previous optical fiber 900 is exhausted. Removing the opticalfiber 900 from the biopsy forceps 10 also allows for the forceps 10 tobe cleaned and sterilized more extensively using more strenuousprocesses. In some sterilization techniques, the optical fiber 900degrades during the cleaning process. Thus, removing the fiber 900during the more strenuous cleaning processes prolongs the useful life ofthe optical fiber 900.

It will be appreciated from the foregoing that we have provided animproved biopsy forceps and system which provides the physician agreater degree of accuracy and control over the biopsy treatment andsampling process than was previously possible. While we have illustratedthe invention with the illustrated embodiments of the invention, it willbe appreciated that variations of shapes, materials and assembly arepossible, within the scope of the invention.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Many other embodiments will beapparent to those of skill in the art upon reviewing the abovedescription. The scope of the invention should, therefore, be determinedwith reference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

What is claimed is:
 1. A biopsy forceps for sampling tissue from an areaof interest, the biopsy forceps comprising:a flexible outer tubularmember having a first lumen therethrough, the outer tubular memberextending from a proximal end to a distal end and adapted for insertioninto a working channel of an endoscope; cutting jaws mounted proximateto the distal end of the outer tubular member for selective opening andclosing in a biopsy cutting movement, the cutting jaws mounted with aclosed cutting position co-axially aligned with the first lumen; aninner tubular member having a second lumen therethrough, the innertubular member extending through the first lumen of the outer tubularmember and operatively connected to open and close the cutting jaws; aremovable optical fiber removably disposed within the second lumen ofthe inner tubular member, the optical fiber extending from a proximalend to a distal end and said proximal end of the optical fiber adaptedfor connection to a spectrophotometric tissue analysis system, saidoptical fiber removable during use of the biopsy forceps; an actuatormechanism coupled with the proximal end of the outer tubular member andthe inner tubular member, where the actuator mechanism is operativelycoupled with the inner tubular member; and an access portcommunicatively coupled with the second lumen.
 2. The biopsy forceps asrecited in claim 1, wherein movement of the inner tubular member causesradial movement of the cutting jaws about fixed pivot pins, said cuttingjaws pivotally mounted to pivot about a common pivotal axis.
 3. Thebiopsy forceps as recited in claim 1, wherein the outer tubular membercomprises a coiled stainless steel tube.
 4. The biopsy forceps asrecited in claim 1, wherein the inner tubular member comprises a coiledstainless steel tube.
 5. The biopsy forceps as recited in claim 1,wherein the actuator mechanism is coupled with the inner tubular membersuch that actuating the actuator mechanism causes axial translation ofthe inner tubular member thereby causing closing and opening movement ofthe cutting jaws aligned with the axis of the inner tubular member. 6.The biopsy forceps as recited in claim 1, wherein the biopsy forcepsfurther comprises an actuator housing having a bore coaxially alignedwith the second lumen, and the actuator housing is coupled with thedistal end of the inner tubular member for actuating the cutting jaws.7. The biopsy forceps as recited in claim 1, wherein the second lumen ofthe inner tubular member has a first diameter and an outer diameter ofthe optical fiber has a second diameter, and the first diameter isgreater than the second diameter and adapted for fluid to be flushedtherethrough.
 8. The biopsy forceps as recited in claim 1, the biopsyforceps further comprising an electrical connection in the proximal endelectrically connected for cauterizing tissue proximate the distal endof the forceps via electrosurgical current.
 9. A biopsy forceps forsampling tissue from an area of interest, the biopsy forcepscomprising:a flexible outer tubular member having a first lumentherethrough, the outer tubular member extending from a proximal end toa distal end and adapted for insertion into a working channel of anendoscope; cutting jaws mounted proximate to the distal end of the outertubular member for selective opening and closing in a biopsy cuttingmovement, the cutting jaws mounted with a closed cutting positionco-axially aligned with the first lumen; and an inner tubular memberhaving a second lumen therethrough, the inner tubular member extendingthrough the first lumen of the outer tubular member and operative toopen and close the cutting jaws; a removable optical fiber removablydisposed within the second lumen of the inner tubular member, theoptical fiber extending from a proximal end to a distal end and saidproximal end of the optical fiber adapted for connection to anelectro-optical histopathological system, said optical fiber removableduring use of the biopsy forceps; a handle portion coupled with theproximal end of the outer tubular member and the inner tubular member,the handle portion comprising: a handle; a translating memberoperatively coupled with the handle and the inner tubular member, wheremoving the handle causes axial movement to the inner tubular member toopen and close the cutting jaws; and an access port communicativelycoupled with the second lumen.
 10. The biopsy forceps as recited inclaim 9, wherein the forceps further comprises an actuator housingoperatively coupled with the inner tubular member and the cutting jaws,and a distal housing coupled with the cutting jaws and the outer tubularmember.
 11. The biopsy forceps as recited in claim 10, wherein theactuator housing has at least two cam pins integral therewith, thecutting jaws each have a cam slot, the distal housing has pivot pinsintegral therewith, and the actuator housing cam pins are received bythe cam slots of the cutting jaws wherein movement of the cam pinscauses radial movement of the cutting jaws about the pivot pins, saidcutting jaws pivotally mounted to pivot about a common pivotal axis. 12.The biopsy forceps as recited in claim 10, wherein the actuator housingcomprises at least a first link and a second link rotatably coupled withthe cutting jaws and the actuator housing, and the distal housing havingat least one pivot pin integral therewith, where the cutting jaws areadapted to rotate about the pivot pins, said cutting jaws pivotallymounted to pivot about a common pivotal axis.
 13. The biopsy forceps asrecited in claim 9, wherein the biopsy forceps further comprises atleast one luer fitting communicatively coupled with the second lumen ofthe inner tubular member.
 14. The biopsy forceps as recited in claim 9,wherein each cutting jaw has a cup portion for receiving the biopsysample therein, and at least one cup has an aperture therein, whereinsaid aperture facilitates the removal of biopsy samples from the cup ofthe cutting jaws.
 15. The biopsy forceps as recited in claim 9, whereinthe inner tubular member has at least two lumens therein, and theoptical fiber is disposed in one of the lumens.
 16. A biopsy forceps forsampling tissue from an area of interest, the biopsy forcepscomprising:a flexible outer tubular member having a first lumentherethrough, the outer tubular member extending from a proximal end toa distal end and adapted for insertion into a working channel of anendoscope; cutting jaws mounted proximate to the distal end of the outertubular member for selective opening and closing in a biopsy cuttingmovement and having a closed cutting position aligned with the firstlumen, the cutting jaws rotatably mounted on pivot pins, said cuttingjaws pivotally mounted to pivot about a common pivotal axis; and aninner tubular member having a second lumen therethrough, the innertubular member extending through the first lumen of the outer tubularmember and having at least one groove disposed therein; a removableoptical fiber disposed within the second lumen of the inner member wherethe optical fiber is affixed to at least a portion of the inner member,the optical fiber extending from a proximal end to a distal end and saidproximal end of the optical fiber adapted for connection to anelectro-optical histopathological analysis system, said optical fiberremovable during use of the biopsy forceps; at least one control wiredisposed in at least one of the grooves of the inner member andextending from the proximal end to the distal end, where the controlwire and the inner member are operatively coupled with the cutting jawssuch that axial movement of the control wire and the inner member causesradial movement of the cutting jaws about stationary pivot pins; and anactuator mechanism coupled with the proximal end of the outer tubularmember and the inner tubular member, where the actuator mechanism isoperatively coupled with the inner tubular member.
 17. The biopsyforceps as recited in claim 16, wherein the inner member has two grooveseach disposed in an outer surface of the inner member, and each groovehaving the control wire disposed therein.
 18. The biopsy forceps asrecited in claim 16, wherein the inner member is comprised of a polymertube.
 19. The biopsy forceps as recited in claim 16, wherein the forcepsfurther comprises an actuator housing operatively coupled with the innertubular member and the cutting jaws, and a distal housing coupled withthe cutting jaws and the outer tubular member.
 20. The biopsy forceps asrecited in claim 19, wherein the actuator housing has at least two campins integral therewith, the cutting jaws each have a cam slot, thedistal housing has pivot pins integral therewith, and the actuatorhousing cam pins are received by the cam slots of the cutting jawswherein movement of the cam pins causes radial movement of the cuttingjaws about the pivot pins about a common pivotal axis.
 21. A biopsyforceps for sampling tissue from an area of interest, the biopsy forcepscomprising:a flexible outer tubular member having a first lumentherethrough, the outer tubular member extending from a proximal end toa distal end and adapted for insertion into a working channel of anendoscope; cutting jaws mounted proximate to the distal end of the outertubular member for selective opening and closing in a biopsy cuttingmovement, the cutting jaws mounted with a closed cutting positionaligned with the first lumen; an inner tubular member having a secondlumen therethrough wherein the second lumen is adapted to receivedevices, the inner tubular member extending through the first lumen ofthe outer tubular member and operative to open and close the cuttingjaws; a removable optical fiber removably disposed within the secondlumen of the inner tubular member, said optical fiber removable duringuse of the biopsy forceps; an actuator mechanism coupled with theproximal end of the outer tubular member and the inner tubular member,where the actuator mechanism is operatively coupled with the innertubular member; a first access port communicatively coupled with thesecond lumen; a third tubular member coupled with an outer surface ofthe outer tubular member, the third tubular member extending from theproximal to the distal ends and having a third lumen therein; and asecond access port coupled with the proximal end of the third tubularmember.
 22. The biopsy forceps as recited in claim 21, wherein theforceps further comprises shrink tubing disposed over the third tubularmember and the outer tubular member.
 23. A biopsy forceps for samplingtissue from an area of interest, the biopsy forceps comprising:aproximal end and a distal end; a flexible outer tubular member having afirst lumen therethrough, the outer tubular member extending from aproximal end to a distal end and adapted for insertion into a workingchannel of an endoscope; cutting jaws mounted proximate to the distalend of the outer tubular member for selective opening and closing in abiopsy cutting movement, the cutting jaws mounted with a closed cuttingposition co-axially aligned with the first lumen; an inner tubularmember having a second lumen therethrough, the inner tubular memberextending through the first lumen of the outer tubular member andoperatively connected to open and close the cutting jaws; an actuatormechanism coupled with the proximal end of the outer tubular member andthe inner tubular member, where the actuator mechanism is operativelycoupled with the inner tubular member; and an access portcommunicatively coupled with the second lumen.
 24. The biopsy forceps ofclaim 23, further comprising a medical instrument removably disposedwithin the second lumen of the inner tubular member extending from aproximal end to a distal end, the medical instrument adapted for use inthe area of interest to treat a biopsy sampling area, the forcepsproviding accurate alignment with repetitive introduction and withdrawalof medical instruments during use.
 25. The biopsy forceps of claim 24,wherein the medical instrument comprises an ultrasonic probe.
 26. Thebiopsy forceps of claim 24, wherein the medical instrument comprises anoptical fiber.
 27. The biopsy forceps of claim 24, wherein the medicalinstrument comprises at least one guidewire.
 28. The biopsy forceps ofclaim 24, wherein the medical instrument comprises a snare.
 29. Thebiopsy forceps of claim 24, wherein the medical instrument comprises acytology brush.
 30. The biopsy forceps of claim 24, wherein the medicalinstrument comprises a needle.
 31. The biopsy forceps of claim 23,wherein the second lumen is adapted for flushing the area of interest.32. The biopsy forceps of claim 23, wherein the second lumen is adaptedfor suctioning the area of interest.
 33. A biopsy forceps for samplingtissue from an area of interest, the biopsy forceps comprising:aflexible outer tubular member having a first lumen therethrough, theouter tubular member extending from a proximal end to a distal end andadapted for insertion into a working channel of an endoscope; cuttingjaws mounted proximate to the distal end of the outer tubular member forselective opening and closing in a biopsy cutting movement, the cuttingjaws mounted with a closed cutting position co-axially aligned with thefirst lumen; and an inner tubular member having a second lumentherethrough, the inner tubular member extending through the first lumenof the outer tubular member and operative to open and close the cuttingjaws; a handle portion coupled with the proximal end of the outertubular member and the inner tubular member, the handle portioncomprising: a handle; a translating member operatively coupled with thehandle and the inner tubular member, where moving the handle causesaxial movement to the inner tubular member to open and close the cuttingjaws; and an access port communicatively coupled with the second lumen.34. The biopsy forceps as recited in claim 33, wherein the forcepsfurther comprises an actuator housing operatively coupled with the innertubular member and the cutting jaws, and a distal housing coupled withthe cutting jaws and the outer tubular member.
 35. The biopsy forceps asrecited in claim 34, wherein the actuator housing has at least two campins integral therewith, the cutting jaws each have a cam slot, thedistal housing has pivot pins integral therewith, and the actuatorhousing cam pins are received by the cam slots of the cutting jawswherein movement of the cam pins causes radial movement of the cuttingjaws about the pivot pins, about a common pivotal axis.
 36. The biopsyforceps as recited in claim 34, wherein the actuator housing comprisesat least a first link and a second link rotatably coupled with thecutting jaws and the actuator housing, and the distal housing havingpivot pins integral therewith, where the cutting jaws are adapted torotate about the pivot pins, about a common pivotal axis.
 37. The biopsyforceps as recited in claim 33, wherein the biopsy forceps furthercomprises at least one luer fitting communicatively coupled with thesecond lumen of the inner tubular member.
 38. The biopsy forceps asrecited in claim 33, wherein each cutting jaw has a cup portion forreceiving the biopsy sample therein, and at least one cup has anaperture therein, wherein said aperture facilitates the removal ofbiopsy samples from the cup of the cutting jaws.
 39. The biopsy forcepsof claim 33, further comprising a removable optical fiber removablydisposed within the second lumen of the inner tubular member, theoptical fiber extending from a proximal end to a distal end and saidproximal end of the optical fiber adapted for connection to anelectro-optical histopathological system, said optical fiber removableduring use of the biopsy forceps.
 40. The biopsy forceps as recited inclaim 39, wherein the inner tubular member has at least two lumenstherein, and the optical fiber is disposed in one of the lumens.
 41. Thebiopsy forceps of claim 33, further comprising a medical instrumentremovably disposed within the second lumen of the inner tubular memberand adapted for use in the area of interest to treat a biopsy samplingarea, the forceps providing accurate alignment with repetitiveintroduction and withdrawal of medical instruments during use.
 42. Thebiopsy forceps of claim 41, wherein the medical instrument comprises anultrasonic probe.
 43. The biopsy forceps of claim 41, wherein themedical instrument comprises at least one guidewire.
 44. The biopsyforceps of claim 41, wherein the medical instrument comprises a snare.45. The biopsy forceps of claim 41 wherein the medical instrumentcomprises a cytology brush.
 46. The biopsy forceps of claim 41, whereinthe medical instrument comprises a needle.
 47. The biopsy forceps ofclaim 33 wherein the second lumen is adapted for flushing the area ofinterest.
 48. The biopsy forceps of claim 33, wherein the second lumenis adapted for suctioning the area of interest.
 49. A biopsy forceps forsampling tissue from an area of interest, the biopsy forcepscomprising:a flexible outer tubular member having a first lumentherethrough, the outer tubular member extending from a proximal end toa distal end and adapted for insertion into a working channel of anendoscope; cutting jaws mounted proximate to the distal end of the outertubular member for selective opening and closing in a biopsy cuttingmovement and having a closed cutting position aligned with the firstlumen, the cutting jaws rotatably mounted on pivot pins, said cuttingjaws pivotally mounted to pivot about a common pivotal axis; and aninner tubular member having a second lumen therethrough, the innertubular member extending through the first lumen of the outer tubularmember and having at least one groove disposed therein; at least onecontrol wire disposed in at least one of the grooves of the inner memberand extending from the proximal end to the distal end, where the controlwire and the inner member are operatively coupled with the cutting jawssuch that axial movement of the control wire and the inner member causesradial movement of the cutting jaws about stationary pivot pins; and anactuator mechanism coupled with the proximal end of the outer tubularmember and the inner tubular member, where the actuator mechanism isoperatively coupled with the inner tubular member.